|
Product Sales Excluding Veklury Increased 8% Year-Over-Year to $26.8 billion for Full Year 2024
|
|
Biktarvy Sales Increased 13% Year-Over-Year to $13.4 billion for Full Year 2024
|
|
Oncology Sales Increased 12% Year-Over-Year to $3.3 billion for Full Year 2024
|
| Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2024. |
| “Gilead delivered another exceptionally strong full year and fourth quarter, with growth in our base business product sales of 8% for 2024 and 13% year-over-year for the fourth quarter,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “From this foundation of commercial strength, we are planning for the potential launch of lenacapavir for HIV PrEP in Summer 2025, with its unique opportunity to extend the reach of HIV prevention. This potential in HIV, along with our strong and diverse portfolio and improved operational efficiencies, positions Gilead to deliver increasing patient impact and compelling shareholder returns in the years ahead.” |
| Fourth Quarter 2024 Financial Results |
- Total fourth quarter 2024 revenue increased 6% to $7.6 billion compared to the same period in 2023, primarily due to higher sales in HIV, as well as in Oncology and Liver Disease, partially offset by lower sales of Veklury® (remdesivir).
|
- Diluted Earnings Per Share (“EPS”) increased to $1.42 in the fourth quarter of 2024 compared to $1.14 in the same period in 2023, primarily driven by lower costs of goods sold, higher product sales and lower acquired in-process research and development (“IPR&D”) expenses, partially offset by higher operating expenses as well as unrealized losses on equity investments in 2024 compared to gains in 2023.
|
- Non-GAAP diluted EPS increased to $1.90 in the fourth quarter of 2024 compared to $1.72 in the same period in 2023. The increase was primarily driven by higher product sales and lower acquired IPR&D expenses, partially offset by higher operating expenses.
|
- As of December 31, 2024, Gilead had $10.0 billion of cash, cash equivalents and marketable debt securities compared to $8.4 billion as of December 31, 2023.
|
- During the fourth quarter of 2024, Gilead generated $3.0 billion in operating cash flow.
|
- During the fourth quarter of 2024, Gilead issued senior unsecured notes in an aggregate principal amount of $3.5 billion, paid cash dividends of $973 million and utilized $350 million to repurchase common stock.
|
| Fourth Quarter 2024 Product Sales |
| Total fourth quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total product sales excluding Veklury increased 13% to $7.2 billion compared to the same period in 2023, primarily due to higher sales in HIV, as well as in Oncology and Liver Disease. |
| HIV product sales increased 16% to $5.5 billion in the fourth quarter of 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favourable inventory dynamics. |
- Biktarvy®(bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 21% to $3.8 billion in the fourth quarter of 2024 compared to the same period in 2023, primarily driven by higher demand, favourable inventory dynamics and higher average realized price.
|
- Descovy®(FTC 200mg/TAF 25mg) sales increased 21% to $616 million in the fourth quarter of 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favourable inventory dynamics.
|
| The Liver Disease portfolio sales increased 4% to $719 million in the fourth quarter of 2024 compared to the same period in 2023. This was primarily driven by the launch of Livdelzi® (seladelpar) in primary biliary cholangitis (“PBC”) and increased demand in products for chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”), partially offset by lower demand and average realized price in products for chronic hepatitis C virus (“HCV”). |
| Veklury sales decreased 53% to $337 million in the fourth quarter 2 of 024 compared to the same period in 2023, primarily driven by lower rates of COVID-19-related hospitalizations, particularly in the United States. |
| Cell Therapy product sales increased 5% to $488 million in the fourth quarter of 2024 compared to the same period in 2023. |
- Yescarta®(axicabtagene ciloleucel) sales increased 6% to $390 million in the fourth quarter of 2024 compared to the same period in 2023, primarily driven by higher average realized price and increased demand outside of the United States, partially offset by lower demand in the United States.
|
- Tecartus®(brexucabtagene autoleucel) sales of $98 million in the fourth quarter of 2024 were flat compared to the same period in 2023, reflecting increased demand outside of the United States, offset by lower demand in the United States.
|
| Trodelvy ® (sacituzumab govitecan-hziy) sales increased 19% to $355 million in the fourth quarter of 2024 compared to the same period in 2023, primarily driven by increased demand in all regions, as well as higher average realized price. |
| Fourth Quarter 2024 Product Gross Margin, Operating Expenses and Tax |
- Product gross margin was 79.0% in the fourth quarter of 2024 compared to 70.4% in the same period in 2023, primarily driven by prior year restructuring expenses related to changes in our manufacturing strategy. Non-GAAP product gross margin was 86.7% in the fourth quarter of 2024 compared to 86.1% in the same period in 2023.
|
- Research and development (“R&D”) expenses were $1.6 billion in the fourth quarter of 2024 compared to $1.4 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio and the impact of a prior year valuation adjustment to the MYR-related contingent consideration that did not repeat. Non-GAAP R&D expenses were $1.6 billion in the fourth quarter of 2024 compared to $1.5 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio.
|
- Acquired IPR&D expenses were $(11) million in the fourth quarter of 2024, reflecting expenses related to the Terray Therapeutics, Inc. (“Terray”) and Tubulis GmbH (“Tubulis”) collaborations, offset by a favourable adjustment related to the CymaBay Therapeutics, Inc. (“CymaBay”) acquisition.
|
- Selling, general and administrative (“SG&A”) and non-GAAP SG&A expenses were $1.9 billion in the fourth quarter of 2024 compared to $1.6 billion in the same period in 2023, primarily driven by a litigation accrual and higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV pre-exposure prophylaxis (“PrEP”) as well as for Livdelzi.
|
- The effective tax rate (“ETR”) was 17.8% in the fourth quarter of 2024 compared to 14.3% in the same period in 2023, primarily due to prior year settlements with tax authorities and non-taxable unrealized gains and losses on equity investments. Non-GAAP ETR was 19.2% in the fourth quarter of 2024 compared to 17.1% in the same period in 2023, primarily due to prior year settlements with tax authorities.
|
| Full Year 2024 Financial Results |
- Total full-year 2024 revenue increased 6% to $28.8 billion compared to 2023, primarily due to higher sales in HIV, Oncology and Liver Disease, partially offset by lower sales of Veklury.
|
- Diluted EPS decreased to $0.38 in the full year 2024 compared to $4.50 in 2023. The decrease was primarily driven by a pre-tax IPR&D impairment charge of $4.2 billion, or $2.49 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020, and acquired IPR&D charges of $3.9 billion, or $3.14 per share, in the first quarter 2024 related to the acquisition of CymaBay, partially offset by higher product sales.
|
- Non-GAAP diluted EPS decreased to $4.62 in the full year 2024 compared to $6.72 in 2023. This was primarily driven by higher acquired IPR&D expenses related to the CymaBay acquisition and higher income tax expenses, partially offset by higher product sales.
|
| Guidance and Outlook |
| For the full-year 2025, Gilead expects: |
| (in millions, except per share amounts) |
|
February 11, 2025 Guidance |
|
Low End |
|
High End |
| Product sales |
|
$ |
28,200 |
|
$ |
28,600 |
|
| Product sales, excluding Veklury |
|
$ |
26,800 |
|
$ |
27,200 |
|
| Veklury |
|
$ |
1,400 |
|
$ |
1,400 |
|
| Diluted EPS |
|
$ |
5.95 |
|
$ |
6.35 |
|
| Non-GAAP diluted EPS |
|
$ |
7.70 |
|
$ |
8.10 |
|
Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 guidance are provided in the accompanying tables. The financial guidance is subject to several risks and uncertainties. See the Forward-Looking Statements section below. |
| Key Updates Since Our Last Quarterly Release |
| Virology |
- Presented new HIV data at the International Congress on Drug Therapy in HIV Infection (“HIV Glasgow 2024”). This included full results from the Phase 3 PURPOSE 2 trial evaluating investigational twice-yearly lenacapavir for HIV prevention among cisgender men and gender-diverse people, with data published in the New England Journal of Medicine.
|
- Additionally, at HIV Glasgow 2024, presented new HIV treatment research data from Biktarvy, as well as for investigational regimens with once-daily, once-weekly and twice-yearly dosing frequencies.
|
- Completed the New Drug Application submissions to the U.S. Food and Drug Administration (“FDA”), as well as a marketing authorization application and an EU-Medicines for All application to the European Medicines Agency (“EMA”) for twice-yearly lenacapavir for HIV prevention.
|
- Lenacapavir was named by Science Magazine as its 2024 “Breakthrough of the Year,” based in part on the PURPOSE 1 and PURPOSE 2 trial results.
|
| Oncology |
- Our partner, Arcellx, Inc. (“Arcellx”), presented new data evaluating investigational anitocabtagene autoleucel (“anito-cel”) in relapsed or refractory (“R/R”) multiple myeloma at the American Society of Hematology 2024 Annual Meeting (“ASH 2024”). This included preliminary data from the registrational Phase 2 iMMagine-1 trial, as well as updated Phase 1 data.
|
- Presented new data at ASH 2024, including long-term follow-up of Yescarta in R/R non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real-world data for Yescarta in R/R large B-cell lymphoma and Tecartus in B-cell precursor adult acute lymphoblastic leukaemia.
|
- Granted Breakthrough Therapy Designation by FDA to Trodelvy for the treatment of adult patients with extensive-stage small cell lung cancer (“ES-SCLC”) whose disease has progressed on or after platinum-based chemotherapy. The use of Trodelvy in ES-SCLC is investigational.
|
- Entered into a single-asset focused collaboration, license, and option agreement with Tubulis to develop an antibody-drug conjugate candidate for a solid tumour target using Tubulis’ Tubutecan and Alco5 platforms.
|
| Inflammation |
- Received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use recommending seladelpar for the treatment of PBC in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA alone or as monotherapy in those unable to tolerate UDCA.
|
- Received marketing authorization from the Medicines and Healthcare Products Regulatory Agency in the UK for seladelpar for treatment of PBC, including pruritus, in adults in combination with UDCA who have an inadequate response to UDCA alone or as monotherapy in those unable to tolerate UDCA.
|
- Presented new data evaluating seladelpar in PBC at the American Association for the Study of Liver Diseases’ The Liver Meeting. This included longer-term follow-up data from the ASSURE trial, as well as additional analyses from the RESPONSE trial.
|
- Announced a strategic partnership to develop and commercialize the pre-clinical oral STAT6 program of LEO Pharma A/S (“LEO Pharma”) for the potential treatment of inflammatory diseases.
|
| Corporate |
- Appointed Dietmar Berger, MD, PhD, as Chief Medical Officer effective January 2025.
|
- Entered into a strategic research collaboration with Terray to discover and develop novel, small molecule therapies across multiple targets using Terray’s artificial intelligence tNOVA platform.
|
- Reached a final settlement agreement with the U.S. Department of Justice and the U.S. Department of Health and Human Services on patents that the government alleged covered Truvada® (FTC 200mg/tenofovir disoproxil fumarate (“TDF”) 300mg) and Descovy for HIV PrEP.
|
- Issued $3.5 billion aggregate principal amount of senior unsecured notes in a registered offering.
|
- The Board declared a quarterly dividend of $0.79 per share of common stock for the first quarter of 2025. The dividend is payable on March 28, 2025, to stockholders of record at the close of business on March 14, 2025. Future dividends will be subject to Board approval.
|
| Certain amounts and percentages in this press release may not be summed or recalculated due to rounding. |
| About Gilead Sciences |
| Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades to create a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. |
| For the full document, click the link below: |
| Gilead Sciences, Inc. |
| Stay ahead of the curve! Subscribe to InsidEntity for daily updates on all your favourite companies. |